Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Rate of Long-term Stent Failure
研究概览
简要总结
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
- •18 years of age or older
- •serum bilirubin > 2mg/dL
排除标准
- •prior endoscopic or percutaneous biliary drainage
- •post-surgical anatomy
- •primary site of biliary obstruction involving the common hepatic duct or hilum
- •tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
研究组 & 干预措施
U-SEMS group
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
干预措施: Uncovered Self-expanding metal biliary stents (U-SEMS) (Device)
C-SEMS Group
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
干预措施: Covered Self-expanding metal biliary stents (C-SEMS) (Device)
结局指标
主要结局
Rate of Long-term Stent Failure
时间窗: One year
Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
次要结局
- Rates of Adverse Stent-related or Intervention-related Outcomes(One Year)
研究者
Patrick Yachimski
Principal Investigator
Vanderbilt University Medical Center